U.S. patent application number 15/368724 was filed with the patent office on 2017-06-08 for rotatable control handles for medical devices and methods of using rotatable control handles.
The applicant listed for this patent is Steen Aggerholm, Kirsten Asser Larsen. Invention is credited to Steen Aggerholm, Kirsten Asser Larsen.
Application Number | 20170157365 15/368724 |
Document ID | / |
Family ID | 57542755 |
Filed Date | 2017-06-08 |
United States Patent
Application |
20170157365 |
Kind Code |
A1 |
Aggerholm; Steen ; et
al. |
June 8, 2017 |
Rotatable Control Handles for Medical Devices and Methods of Using
Rotatable Control Handles
Abstract
Rotatable control handles and methods of using rotatable control
handles are described herein. An example embodiment of a rotatable
control handle comprises a handle, a compressible member disposed
within the handle, a cap attached to the handle, and a cannula
rotatably attached between the handle and the cap. The handle
comprises a first member and a second member that is releasably
attachable to the first member.
Inventors: |
Aggerholm; Steen; (St.
Heddinge, DK) ; Larsen; Kirsten Asser; (Moerkoev,
DK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Aggerholm; Steen
Larsen; Kirsten Asser |
St. Heddinge
Moerkoev |
|
DK
DK |
|
|
Family ID: |
57542755 |
Appl. No.: |
15/368724 |
Filed: |
December 5, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62263904 |
Dec 7, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 2025/09116
20130101; A61B 17/3476 20130101; G05G 1/10 20130101; A61B 17/3498
20130101; A61B 17/3423 20130101; A61B 17/3468 20130101; G05G
2700/12 20130101; A61M 25/09041 20130101 |
International
Class: |
A61M 25/09 20060101
A61M025/09; A61B 17/34 20060101 A61B017/34; G05G 1/10 20060101
G05G001/10 |
Claims
1. A rotatable control handle comprising: a handle having a first
member and a second member releasably attached to the first member,
the handle moveable between a first configuration in which the
first member is free of attachment to the second member and a
second configuration in which the first member is releasably
attached to the second member; a compressible member partially
disposed within the first member and the second member and movable
between a first configuration when the handle is in the first
configuration and a second configuration when the handle is in the
second configuration, the compressible member having a compressible
member first end, a compressible member second end, and a
compressible member body defining a base and a plurality of arms,
the plurality of arms extending from the base and cooperatively
defining a first inside diameter when the compressible member is in
the first configuration and a second inside diameter when the
compressible member is in the second configuration, the second
inside diameter less than the first inside diameter; a cap attached
to the handle and having a cap first end, a cap second end, and a
cap body defining a cap recess and a cap passageway, the cap recess
extending into the cap body from the cap first end toward the cap
second end, the cap passageway extending from the cap second end to
the cap recess and in communication with the cap recess; and a
cannula rotatably attached to the cap and partially disposed within
the cap recess and between the second member and the cap, the
cannula disposed though the cap passageway and having a cannula
first end, a cannula second end, and a cannula body defining a
cannula passageway extending from the cannula first end to the
cannula second end.
2. The rotatable control handle of claim 1, wherein the first
member has a first member first end, a first member second end, and
a first member body defining a first member passageway and a first
member recess, the first member passageway extending from the first
member first end toward the first member second end, the first
member recess extending from the first member second end toward the
first member first end and in communication with the first member
passageway; wherein the second member has a second member first
end, a second member second end, and a second member body defining
a second member first recess, a second member second recess, and a
second member passageway, the second member first recess extending
from the second member first end toward the second member second
end, the second member second recess extending from the second
member second end toward the second member first end, the second
member passageway extending from the second member first recess to
the second member second recess and in communication with the
second member first recess and second member second recess; and
wherein the compressible member is partially disposed within the
first member recess and the second member first recess.
3. The rotatable control handle of claim 2, wherein the first
member passageway has a third inside diameter and the first member
recess has a fourth inside diameter that is greater than the third
inside diameter.
4. The rotatable control handle of claim 2, wherein the second
member first recess has a third inside diameter, the second member
second recess has a fourth inside diameter, and the second member
passageway has a fifth inside diameter that is less than the third
inside diameter and the fourth inside diameter.
5. The rotatable control handle of claim 4, wherein the second
member passageway has a sixth inside diameter that is less than the
fifth inside diameter.
6. The rotatable control handle of claim 2, wherein the second
member body defines a second member projection extending into the
second member second recess; and wherein the cap body defines a
recess that extends into the cap body that is sized and configured
to receive a portion of the second member projection.
7. The rotatable control handle of claim 1, further comprising a
guide member disposed between the cannula and the cap, the guide
member having a guide member first end, a guide member second end,
and a guide member body defining a guide member passageway, the
guide member passageway extending from the guide member first end
to the guide member second end; wherein the cannula is partially
disposed between the second member and the guide member.
8. The rotatable control handle of claim 7, wherein the guide
member passageway has a third inside diameter and a fourth inside
diameter that is less than the third inside diameter.
9. The rotatable control handle of claim 1, wherein the plurality
of arms comprises a first arm, a second arm, a third arm, and a
fourth arm, the compressible member body defining a projection and
a notch on each of the first arm, the second arm, the third arm,
and the fourth arm.
10. The rotatable control handle of claim 9, wherein the notch
defined on the first arm is disposed a first distance from the
compressible member second end; wherein the projection defined on
the first arm is disposed a second distance from the compressible
member second end; and wherein the second distance is different
than the first distance.
11. The rotatable control handle of claim 1, wherein the cap is
rotatably attached to the handle.
12. A rotatable control handle comprising: a handle having a first
member and a second member releasably attached to the first member,
the handle moveable between a first configuration in which the
first member is free of attachment to the second member and a
second configuration in which the first member is releasably
attached to the second member, the first member having a first
member first end, a first member second end, and a first member
body defining a first member passageway and a first member recess,
the first member passageway extending from the first member first
end toward the first member second end, the first member recess
extending from the first member second end toward the first member
first end and in communication with the first member passageway,
the second member having a second member first end, a second member
second end, and a second member body defining a second member first
recess, a second member second recess, and a second member
passageway, the second member first recess extending from the
second member first end toward the second member second end, the
second member second recess extending from the second member second
end toward the second member first end, the second member
passageway extending from the second member first recess to the
second member second recess and in communication with the second
member first recess and second member second recess; a compressible
member partially disposed within the first member recess and the
second member first recess and movable between a first
configuration when the handle is in the first configuration and a
second configuration when the handle is in the second
configuration, the compressible member having a compressible member
first end, a compressible member second end, and a compressible
member body defining a base and a plurality of arms, the plurality
of arms extending from the base and cooperatively defining a first
inside diameter when the compressible member is in the first
configuration and a second inside diameter when the compressible
member is in the second configuration, the second inside diameter
less than the first inside diameter; a cap attached to the handle
and having a cap first end, a cap second end, and a cap body
defining a cap recess and a cap passageway, the cap recess
extending into the cap body from the cap first end toward the cap
second end, the cap passageway extending from the cap second end to
the cap recess and in communication with the cap recess; a guide
member disposed between the second member and the cap, the guide
member having a guide member first end, a guide member second end,
and a guide member body defining a guide member passageway, the
guide member passageway extending from the guide member first end
to the guide member second end; and a cannula rotatably attached to
the cap and partially disposed within the cap recess and between
the second member and the guide member, the cannula disposed
through the cap passageway and having a cannula first end, a
cannula second end, and a cannula body defining a cannula
passageway extending from the cannula first end to the cannula
second end.
13. The rotatable control handle of claim 12, wherein the guide
member passageway has a third inside diameter and a fourth inside
diameter that is less than the third inside diameter.
14. The rotatable control handle of claim 12, wherein the first
member passageway has a third inside diameter and the first member
recess has a fourth inside diameter that is greater than the third
inside diameter.
15. The rotatable control handle of claim 12, wherein the second
member first recess has a third inside diameter, the second member
second recess has a fourth inside diameter, and the second member
passageway has a fifth inside diameter that is less than the third
inside diameter and the fourth inside diameter.
16. The rotatable control handle of claim 15, wherein the second
member passageway has a sixth inside diameter that is less than the
fifth inside diameter.
17. The rotatable control handle of claim 12, wherein the second
member body defines a second member projection extending into the
second member second recess; and wherein the cap body defines a
recess that extends into the cap body that is sized and configured
to receive a portion of the second member projection.
18. The rotatable control handle of claim 12, wherein the plurality
of arms comprises a first arm, a second arm, a third arm, and a
fourth arm, the compressible member body defining a projection and
a notch on each of the first arm, the second arm, the third arm,
and the fourth arm.
19. The rotatable control handle of claim 18, wherein the notch
defined on the first arm is disposed a first distance from the
compressible member second end; wherein the projection defined on
the first arm is disposed a second distance from the compressible
member second end; and wherein the second distance is different
than the first distance.
20. A method of using a rotatable control handle, the method
comprising the steps of: positioning a rotatable control handle on
a medical device having a medical device first end and a medical
device second end, the rotatable control handle comprising: a
handle having a first member and a second member releasably
attachable to the first member, the handle moveable between a first
configuration in which the first member is free of attachment to
the second member and a second configuration in which the first
member is releasably attached to the second member; a compressible
member partially disposed within the first member and the second
member and movable between a first configuration when the handle is
in the first configuration and a second configuration when the
handle is in the second configuration, the compressible member
having a compressible member first end, a compressible member
second end, and a compressible member body defining a base and a
plurality of arms, the plurality of arms extending from the base
and cooperatively defining a first inside diameter when the
compressible member is in the first configuration and a second
inside diameter when the compressible member is in the second
configuration, the second inside diameter less than the first
inside diameter; a cap attached to the handle and having a cap
first end, a cap second end, and a cap body defining a cap recess
and a cap passageway, the cap recess extending into the cap body
from the cap first end toward the cap second end, the cap
passageway extending from the cap second end to the cap recess and
in communication with the cap recess; and a cannula rotatably
attached to the cap and partially disposed within the cap recess
and between the second member and the cap, the cannula disposed
though the cap passageway and having a cannula first end, a cannula
second end, and a cannula body defining a cannula passageway
extending from the cannula first end to the cannula second end;
moving the handle of the rotatable control handle from the first
configuration to the second configuration such that the rotatable
control handle is attached to the medical device; applying an axial
force on the rotatable control handle directed toward a valve
device having a housing and a valve member such that the medical
device is advanced through the valve member of the valve device and
the first end of the medical device is disposed on a first side of
the valve member and the second end of the medical device is
disposed on a second side of the valve member; continuing the
application of an axial force on the rotatable control handle such
that the rotatable control handle and the medical device are
advanced through the valve member of the valve device and the first
end of the cannula is disposed on the second side of the valve
member and the second end of the cannula is disposed on the first
side of the valve member; applying torque to the handle of the
rotatable control handle such that the handle and medical device
rotate relative to the valve device; moving the handle of the
rotatable control handle from the second configuration to the first
configuration; applying axial force on the medical device such that
the medical device moves relative to the handle; moving the handle
of the rotatable control handle from the first configuration to the
second configuration; and applying an axial force on the rotatable
control handle directed away from the valve device such that the
rotatable control handle and the medical device are withdrawn from
the valve member of the valve device, the second end of the cannula
is disposed on the second side of the valve member, and the medical
device and rotatable control handle are free of the valve device.
Description
RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 62/263,904, filed Dec. 7, 2015. The entire
disclosure of this related application is hereby incorporated into
this disclosure by reference.
FIELD
[0002] The disclosure relates generally to the field of medical
devices and methods of using medical devices. More particularly,
the disclosure relates to the field of control handles for medical
devices, such as guidewires, and methods of using control
handles.
BACKGROUND
[0003] Numerous procedures have been developed that require the
percutaneous insertion of one or more medical devices into the body
of a patient. Such procedures include, for example, percutaneous
transluminal coronary angioplasty (PTCA), X-ray angiographic
procedures, embolization procedures, and the like. The medical
devices intended for use in such procedures may be introduced into
the vascular system by a variety of known techniques. For example,
in the widely used Seldinger technique, a surgical opening is made
in a body vessel, such as an artery or vein, by a needle, and a
guidewire is inserted into the body vessel through a bore in the
needle. The needle is then withdrawn, leaving the guidewire in
place. A dilator positioned within the lumen of an introducer
device is then inserted over the guidewire and advanced into the
body vessel. Once the introducer is positioned as desired within
the body vessel, the dilator is withdrawn. A variety of medical
devices, such as catheters, delivery systems, cardiac leads, and
the like, can then be advanced through the introducer to a point of
treatment in the body vessel. For example, a delivery system that
includes a guidewire with an attached embolization coil can be
introduced through the introducer to a point of treatment and
delivered using conventional techniques (e.g., rotating the
guidewire such that the embolization coil becomes free of the
guidewire).
[0004] In many cases, an introducer will include one or more
hemostatic valve members (also referred to as check valves) for
inhibiting leakage of bodily fluids, such as blood, through the
introducer as a medical device is inserted through or withdrawn
from the introducer. In some cases, hemostatic valves that include
a valve member, such as an elastomeric member, are used to minimize
fluid leakage during these exchanges. Hemostatic valves of this
type are dependent upon the ability of the valve member to seal
around the interventional devices to close any gaps created upon
insertion or withdrawal of the device through the valve.
[0005] The introduction and maneuvering of medical devices, such as
guidewires, through a valve member of a hemostatic valve present
various challenges. For example, when disposed through a valve
member, a guidewire can be difficult to introduce and withdraw from
the valve member and rotation of the guidewire relative to the
valve member can require two hands, which increases the complexity
of the procedure. In addition, the manipulation of the guidewire
through the valve member sometimes results in the guidewire
becoming kinked, which may result in the guidewire becoming
unsuitable for continued use throughout the remainder of the
procedure. Control handles for guidewires have been developed that
can be used during the performance of a procedure. However, these
devices fail to provide support for the guidewire through valve
members and also fail to provide a mechanism for rotating the
guidewire relative to a portion of the control handle when the
guidewire is disposed through a valve member. Thus, there is a need
for improved rotatable control handles and methods of using
rotatable control handles.
BRIEF SUMMARY OF SELECTED EXAMPLE EMBODIMENTS
[0006] Rotatable control handles useful for controlling the
position of a medical device are provided. An example rotatable
control handle comprises a handle, a compressible member, a cap,
and a cannula. The handle has a first member and a second member
that is releasably attached to the first member. The handle is
moveable between a first configuration in which the first member is
free of attachment to the second member and a second configuration
in which the first member is releasably attached to the second
member. The compressible member is partially disposed within the
first member and the second member and is movable between a first
configuration when the handle is in the first configuration and a
second configuration when the handle is in the second
configuration. The compressible member has a compressible member
first end, a compressible member second end, and a compressible
member body that defines a base and a plurality of arms. The
plurality of arms extends from the base and cooperatively defines a
first inside diameter when the compressible member is in the first
configuration and a second inside diameter when the compressible
member is in the second configuration. The second inside diameter
is less than the first inside diameter. The cap is attached to the
handle and has a cap first end, a cap second end, and a cap body
that defines a cap recess and a cap passageway. The cap recess
extends into the cap body from the cap first end toward the cap
second end. The cap passageway extends from the cap second end to
the cap recess and is in communication with the cap recess. The
cannula is rotatably attached to the cap and is partially disposed
within the cap recess and between the second member and the cap.
The cannula is disposed through the cap passageway and has a
cannula first end, a cannula second end, and a cannula body that
defines a cannula passageway that extends from the cannula first
end to the cannula second end.
[0007] Another example rotatable control handle comprises a handle,
a compressible member, a cap, a guide member, and a cannula. The
handle has a first member and a second member that is releasably
attached to the first member. The handle is moveable between a
first configuration in which the first member is free of attachment
to the second member and a second configuration in which the first
member is releasably attached to the second member. The first
member has a first member first end, a first member second end, and
a first member body that defines a first member passageway and a
first member recess. The first member passageway extends from the
first member first end toward the first member second end. The
first member recess extends from the first member second end toward
the first member first end and is in communication with the first
member passageway. The second member has a second member first end,
a second member second end, and a second member body that defines a
second member first recess, a second member second recess, and a
second member passageway. The second member first recess extends
from the second member first end toward the second member second
end. The second member second recess extends from the second member
second end toward the second member first end. The second member
passageway extends from the second member first recess to the
second member second recess and is in communication with the second
member first recess and second member second recess. The
compressible member is partially disposed within the first member
recess and the second member first recess and is movable between a
first configuration when the handle is in the first configuration
and a second configuration when the handle is in the second
configuration. The compressible member has a compressible member
first end, a compressible member second end, and a compressible
member body that defines a base and a plurality of arms. The
plurality of arms extends from the base and cooperatively defines a
first inside diameter when the compressible member is in the first
configuration and a second inside diameter when the compressible
member is in the second configuration. The second inside diameter
is less than the first inside diameter. The cap is attached to the
handle and has a cap first end, a cap second end, and a cap body
that defines a cap recess and a cap passageway. The cap recess
extends into the cap body from the cap first end toward the cap
second end. The cap passageway extends from the cap second end to
the cap recess and is in communication with the cap recess. The
guide member is disposed between the second member and the cap and
has a guide member first end, a guide member second end, and a
guide member body that defines a guide member passageway. The guide
member passageway extends from the guide member first end to the
guide member second end. The cannula is rotatably attached to the
cap and is partially disposed within the cap recess and between the
second member and the guide member. The cannula is disposed through
the cap passageway and has a cannula first end, a cannula second
end, and a cannula body that defines a cannula passageway that
extends from the cannula first end to the cannula second end.
[0008] Another example rotatable control handle comprises a handle,
a compressible member, a cap, a guide member, and a cannula. The
handle has a first member and a second member that is releasably
attached to the first member. The handle is moveable between a
first configuration in which the first member is free of attachment
to the second member and a second configuration in which the first
member is releasably attached to the second member. The first
member has a first member first end, a first member second end, and
a first member body that defines a first member passageway and a
first member recess. The first member passageway extends from the
first member first end toward the first member second end. The
first member recess extends from the first member second end toward
the first member first end and is in communication with the first
member passageway. The second member has a second member first end,
a second member second end, and a second member body that defines a
second member first recess, a second member second recess, and a
second member passageway. The second member first recess extends
from the second member first end toward the second member second
end. The second member second recess extends from the second member
second end toward the second member first end. The second member
passageway extends from the second member first recess to the
second member second recess and is in communication with the second
member first recess and second member second recess. The
compressible member is partially disposed within the first member
recess and the second member first recess and is movable between a
first configuration when the handle is in the first configuration
and a second configuration when the handle is in the second
configuration. The compressible member has a compressible member
first end, a compressible member second end, and a compressible
member body that defines a base, a first arm that extends from the
base, a second arm that extends from the base, a third arm that
extends from the base, and a fourth arm that extends from the base.
The compressible member body defines a projection and a notch on
each of the first arm, the second arm, the third arm, and the
fourth arm. The first arm, the second arm, the third arm, and the
fourth arm cooperatively define a first inside diameter when the
compressible member is in the first configuration and a second
inside diameter when the compressible member is in the second
configuration. The second inside diameter is less than the first
inside diameter. The notch defined on the first arm is disposed a
first distance from the compressible member second end. The
projection defined on the first arm is disposed a second distance
from the compressible member second end that is different than the
first distance. The cap is attached to the handle and has a cap
first end, a cap second end, and a cap body that defines a cap
recess and a cap passageway. The cap recess extends into the cap
body from the cap first end toward the cap second end. The cap
passageway extends from the cap second end to the cap recess and is
in communication with the cap recess. The guide member is disposed
between the second member and the cap and has a guide member first
end, a guide member second end, and a guide member body that
defines a guide member passageway. The guide member passageway
extends from the guide member first end to the guide member second
end and has a third inside diameter and a fourth inside diameter
that is less than the third inside diameter. The cannula is
rotatably attached to the cap and is partially disposed within the
cap recess and between the second member and the guide member. The
cannula is disposed through the cap passageway and has a cannula
first end, a cannula second end, and a cannula body that defines a
cannula passageway that extends from the cannula first end to the
cannula second end.
[0009] Methods of using a rotatable control handle are also
provided. An example method of using a rotatable control handle
comprises the steps of: positioning a rotatable control handle on a
medical device having a medical device first end and a medical
device second end; moving the handle of the rotatable control
handle from a first configuration to a second configuration;
applying an axial force on the rotatable control handle directed
toward a valve device having a housing and a valve member such that
the medical device is advanced through the valve member of the
valve device and the first end of the medical device is disposed on
a first side of the valve member and the second end of the medical
device is disposed on a second side of the valve member; continuing
the application of an axial force on the rotatable control handle
such that the rotatable control handle and the medical device are
advanced through the valve member of the valve device and the first
end of the cannula of the rotatable control handle is disposed on
the second side of the valve member and the second end of the
cannula is disposed on the first side of the valve member; applying
torque to the handle of the rotatable control handle such that the
handle and medical device rotate relative to the valve device;
moving the handle of the rotatable control handle from a second
configuration to a first configuration; applying axial force on the
medical device such that the medical device moves relative to the
handle; moving the handle of the rotatable control handle from the
first configuration to the second configuration; applying an axial
force on the rotatable control handle directed away from the valve
device such that the rotatable control handle and the medical
device are withdrawn from the valve member of the valve device, the
second end of the cannula of the rotatable control handle is
disposed on the second side of the valve member, and the medical
device and rotatable control handle are free of the valve
device.
[0010] Additional understanding of the exemplary rotatable control
handles and methods of using rotatable control handles can be
obtained by review of the detailed description, below, and the
appended drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a perspective view of an example embodiment of a
rotatable control handle.
[0012] FIG. 2 is an exploded view of the rotatable control handle
illustrated in FIG. 1.
[0013] FIG. 3 is a partial sectional view of the rotatable control
handle illustrated in FIG. 1 taken along the lengthwise axis of the
rotatable control handle.
[0014] FIG. 4 is an exploded sectional view of the handle of the
rotatable control handle illustrated in FIG. 1 taken along the
lengthwise axis of the handle.
[0015] FIG. 5 is a perspective view of the compressible member of
the rotatable control handle illustrated in FIG. 1. The
compressible member is in a first configuration.
[0016] FIG. 5A is an elevation view of the compressible member
illustrated in FIG. 5. The compressible member is in a first
configuration.
[0017] FIG. 5B is an end view of the second end of the compressible
member illustrated in FIG. 5. The compressible member is in a first
configuration.
[0018] FIG. 5C is an elevation view of the compressible member
illustrated in FIG. 5. The compressible member is in a second
configuration.
[0019] FIG. 5D is an end view of the second end of the compressible
member illustrated in FIG. 5. The compressible member is in a
second configuration.
[0020] FIG. 6 is a sectional view of the cap of the rotatable
control handle illustrated in FIG. 1 taken along the lengthwise
axis of the cap.
[0021] FIG. 7 is a sectional view of the guide member of the
rotatable control handle illustrated in FIG. 1 taken along the
lengthwise axis of the guide member.
[0022] FIG. 8 is a sectional view, partially broken away, of the
cannula of the rotatable control handle illustrated in FIG. 1 taken
along the lengthwise axis of the cannula.
[0023] FIG. 9 is an elevation view of an alternative compressible
member that can be included in a rotatable control handle.
[0024] FIG. 10 is a sectional view of an alternative cap that can
be included in a rotatable control handle taken along the
lengthwise axis of the cap.
[0025] FIG. 11 is a schematic illustration of an example method of
using a rotatable control handle.
[0026] FIG. 12 is a partial elevation view of a rotatable control
handle attached to a guidewire. The guidewire is partially disposed
through a valve device.
[0027] FIG. 13 is a partial elevation view of a rotatable control
handle attached to a guidewire. The guidewire and the cannula of
the rotatable control handle are partially disposed through a valve
device.
[0028] FIG. 14 is a perspective view of another alternative
compressible member that can be included in a rotatable control
handle.
[0029] FIG. 15 is a cross-sectional view of the compressible member
illustrated in FIG. 14 taken along line 15-15.
[0030] FIG. 16 is a perspective view of another alternative
compressible member that can be included in a rotatable control
handle.
[0031] FIG. 17A is a cross-sectional view of the compressible
member illustrated in FIG. 16 taken along line 17-17.
[0032] FIG. 17B illustrates the compressible member shown in FIG.
17A in a second configuration.
DETAILED DESCRIPTION
[0033] The following detailed description and the appended drawings
describe and illustrate various example embodiments of a rotatable
control handle that can be used with various medical devices and
methods of using a rotatable control handle. The description and
illustration of these examples are provided to enable one skilled
in the art to make and use a rotatable control handle and to
practice a method of using a rotatable control handle. They are not
intended to limit the scope of the claims in any manner.
[0034] The use of "e.g.," "example," and "or," and grammatically
related terms, indicate non-exclusive alternatives without
limitation, unless otherwise noted. The term "diameter" refers to
the length of a straight line passing from side to side through the
center of a body, element, or feature, and does not impart any
structural configuration on the body, element, or feature. The
recitation of a first structural feature "circumferentially
adjacent" to a second structural feature means that the first
structural feature is the nearest first structural feature to the
second structural feature when moving along an imaginary line that
extends from the first structural feature to the second structural
feature.
[0035] FIGS. 1, 2, 3, 4, 5, 5A, 5B, 5C, 5D, 6, 7, and 8 illustrate
a rotatable control handle 10 for use on a medical device, such as
a guidewire. The control handle 10 has a lengthwise axis 11, a
first end 12, a second end 14, and comprises a handle 16, a
compressible member 18, a cap 20, a guide member 22, and a cannula
24.
[0036] As illustrated in FIG. 4, the handle 16 has a first member
30 that is releasably attachable to a second member 32. The handle
16 is moveable between a first configuration in which the first
member 30 is free of attachment to the second member 32, and a
second configuration in which the first member 30 is releasably
attached to the second member 32. The first member 30 has a first
end 34, a second end 36, and a body 38 that defines a passageway
40, a recess 42, and threads 44. The passageway 40 extends through
a portion of the body 38 and from the first end 34 toward the
second end 36 of the first member 30 and is in communication with
the recess 42. The passageway 40 has a passageway diameter 41 that
is sized and configured to receive a medical device, such as a
guidewire. The recess 42 extends into the body 38 from the second
end 36 toward the first end 34 of the first member 30. The recess
42 has a recess diameter 43 and a length 45 that is sized and
configured to house a portion of the compressible member 18, as
described in more detail herein. The recess diameter 43 is greater
than the passageway diameter 41. The threads 44 extend from the
second end 36 toward the first end 32 and are sized and configured
to mate with the threads 60 defined by the second member 32 of the
handle 16, as described in more detail herein.
[0037] The second member 32 of the handle 16 is releasably
attachable to the first member 30 when the handle 16 is in the
second configuration. As illustrated in FIG. 1, the second member
32 is releasably attached to the first member 30. The second member
32 has a first end 46, a second end 48, and a body 50 that defines
a first recess 52, a second recess 54, a projection 56, a
passageway 58, and threads 60. In the illustrated embodiment, the
second member 32 has a length that extends from the first end 46 to
the second end 48 that is equal to about 18 millimeters and has a
diameter at the first end 46 that is equal to about 14.5
millimeters. The first recess 52 extends into the body 50 from the
first end 46 toward the second end 48 and has a first recess
diameter 53 that is sized and configured to receive a portion of
the first member 30 and a portion of the compressible member 18. In
the illustrated embodiment, the first recess diameter 53 is equal
to about 6.35 millimeters and has a length that extends from the
first end 46 to the passageway 58 that is equal to about 8
millimeters. The first recess 52 is in communication with the
passageway 58. The second recess 54 extends into the body 50 from
the second end 48 toward the first end 46 and has a second recess
diameter 55 that is greater than the first recess diameter 53 and
is sized and configured to receive a portion of the cap 20, guide
member 22, and cannula 24. In the illustrated embodiment, the
second recess diameter 55 is equal to about 11 millimeters and has
a length that extends from the second end 48 to the passageway 58
that is equal to about 8 millimeters. The second recess 54 is in
communication with the passageway 58. The projection 56 extends
into the second recess 54 and toward the lengthwise axis of the
second member 32 and defines a projection diameter 57 within the
second recess 54 that is less than the second recess diameter 55.
The projection 56 provides structure for rotatably attaching the
cap 20 to the handle 16, as described in more detail herein. In the
illustrated embodiment, the projection diameter 57 is equal to
about 10.3 millimeters. The passageway 58 extends through a portion
of the body 50 of the second member 32 and from the first recess 52
to the second recess 54 such that the passageway 58 is in
communication with each of the first recess 52 and the second
recess 54. The passageway 58 has a first passageway diameter 59 at
the opening in communication with the first recess 52 and a second
passageway diameter 61 at the opening in communication with the
second recess 54. The first passageway diameter 59 is greater than
the second passageway diameter 61. In the illustrated embodiment,
the second passageway diameter 61 is equal to about 1.1
millimeters. The diameter of the passageway 58 tapers from the
first passageway diameter 59 to the second passageway diameter 61
along a first portion of the length of the passageway 58 that
extends from the first recess 52 toward the second recess 54 such
that the wall of the passageway 58 along the first portion of the
length of the passageway 58 is disposed at an angle equal to about
30 degrees relative to the lengthwise axis of the second member 32.
The passageway 58 is sized and configured to receive a medical
device, such as a guidewire. In the illustrated embodiment, the
first portion of the passageway 58 has a length that extends from
the first recess 52 to a second portion of the passageway that is
equal to about 0.9 millimeters.
[0038] While the handle 16 has been illustrated as having a
particular structural configuration and having particular
dimensions, a handle included in a rotatable control handle can
have any suitable structural configuration and can have any
suitable dimensions. Selection of a suitable structural
configuration and dimensions for a handle can be based on various
considerations, such as the structural configuration of a
compressible member included in the rotatable control handle and/or
the material(s) that forms the medical device on which the handle
is intended to be disposed. For example, the first member and/or
second member of a handle can define one or more recesses and/or
projections on an exterior surface that are sized and configured to
provide tactile feedback as to the movement of the member during
use. Alternative to the configuration illustrated in FIGS. 1, 2, 3,
and 4, a handle can omit the inclusion of the projection and/or the
handle included in a rotatable control handle can define a
compressible member (e.g., collet) such that the handle can be
directly attached to a medical device, such as a guidewire, without
the inclusion of a separate component (e.g., compressible member
18).
[0039] While the first member 30 has been illustrated as being
attached to the second member 32 using a threaded connection, a
first member can be releasably attached to a second member using
any technique or method of attachment considered suitable for a
particular embodiment. Selection of a suitable technique or method
of attachment between a first member and a second member can be
based on various considerations, such as the material(s) that forms
a first member to which a second member is intended to be attached.
Examples of techniques and methods of attachment considered
suitable between a first member and a second member include snap
fit configurations, threaded connections, and any other technique
or method of attachment considered suitable for a particular
embodiment. For example, alternative to the first member defining
threads on an exterior surface and the second member defining
threads within a recess, a first member can define threads within a
recess that are sized and configured to mate with threads defined
on an exterior surface of a second member. In this alternative
configuration, the first member defines a recess sized and
configured to receive a portion of the second member and a portion
of the compressible member and the second member defines a recess
that is sized and configured to receive a portion of the
compressible member.
[0040] In the illustrated embodiment, the compressible member 18
has a lengthwise axis 63, a first end 64, a second end 66, a length
67, and a body 68 that defines a base 70, a passageway 72, a first
arm 74, a second arm 76, a third arm 78, and a fourth arm 80. The
compressible member 18 is moveable between a first configuration,
as shown in FIGS. 5, 5A, and 5B, and a second configuration, as
shown in FIGS. 5C and 5D. The compressible member 18 is in the
first configuration when the handle 16 is in the first
configuration and the compressible member 18 is in the second
configuration when the handle 16 is in the second configuration.
The length 67 of the compressible member 18 extends from the first
end 64 to the second end 66 and is greater than the length 45 of
the recess 42 defined by the first member 30. The base 70 has an
outside diameter 71, a first end 82, and a second end 84. The
outside diameter 71 of the base 70 is sized and configured to be
received by the recess 42 defined by the first member 30. The
passageway 72 extends through the base 70 from a first opening
defined on the first end 82 of the base 70 to a second opening
defined on the second end 84 of the base 70. The passageway 72 is
sized and configured to receive a medical device, such as a
guidewire, and, when the rotatable medical device 10 is assembled
as illustrated in FIG. 1, is coaxial with the passageway 40 defined
by the first member 30 and the passageway 58 defined by the second
member 32.
[0041] Each of the arms 74, 76, 78, 80 extends from the base 70 to
the second end 66 of the compressible member 18 and is moveable
between a first position, as illustrated in FIGS. 5, 5A, and 5B,
and a second position, as illustrated in FIGS. 5C and 5D. Each of
the arms 74, 76, 78, 80 is in the first position when the
compressible member 18 is in the first configuration and each of
the arms 74, 76, 78, 80 is in the second position when the
compressible member 18 is in the second configuration. Each of the
arms 74, 76, 78, 80 has a first end 86 attached to the base 70, a
second end 88, a length 89, a shaft 90, and a head 92. The length
89 extends from the first end 86 to the second end 88 and, in the
illustrated embodiment, is equal to about 8.8 millimeters. The
shaft 90 extends from a first end attached to the base 70 to a
second end attached to the head 92 such that the shaft 90 is
disposed between the base 70 and the head 92. The head 92 extends
from the shaft 90 to the second end 66 of the compressible member
18. The body 68 of the compressible member 18 defines a notch 94
and a projection 96 on the head 92 of each of the arms 74, 76, 78,
80. The notch 94 of each arm 74, 76, 78, 80 is sized and configured
to receive a projection of a circumferentially adjacent arm when
the compressible member 18 is in the second configuration, as
illustrated in FIGS. 5C and 5D. In the illustrated embodiment, the
notch 94 is a triangular prismatic notch that extends into the arm
a length equal to about 0.9 millimeters and the projection 96 is a
triangular prismatic projection that extends from the arm a length
equal to about 0.7 millimeters. The notch 94 is positioned on a
first side of the head 92 and the projection 96 is positioned on a
second side of the head 92 such that a portion of the notch 94 is
disposed on a first plane and a portion of the projection 96 is
disposed on a second plane that is positioned orthogonal to the
first plane. In the illustrated embodiment, when the compressible
member 18 is in the first configuration, the projection 96 is
partially disposed in the notch 94 of a circumferentially adjacent
arm a length equal to about 0.1 millimeters.
[0042] In the illustrated embodiment, the first arm 74 defines the
notch 94 a first distance from the second end 66 of the
compressible member 18 and the projection 96 a second distance from
the second end 66 of the compressible member 18 that is greater
than the first distance. The second arm 76 defines the notch 94 a
third distance from the second end 66 of the compressible member 18
and the projection 96 a fourth distance from the second end 66 of
the compressible member 18 that is less than the third distance.
The third distance is equal to the second distance. The third arm
78 defines the notch 94 a fifth distance from the second end 66 of
the compressible member 18 and the projection 96 a sixth distance
from the second end 66 of the compressible member 18 that is
greater than the third distance. The fifth distance is equal to the
fourth distance. The fourth arm 80 defines the notch 94 a seventh
distance from the second end 66 of the compressible member 18 and
the projection 96 an eighth distance from the second end 66 of the
compressible member 18 that is less than the third distance. The
seventh distance is equal to the sixth distance and the eighth
distance is equal to the first distance. In the illustrated
embodiment, the first distance, the fourth distance, the fifth
distance, and the eighth distance are equal to one another and
equal to about 1.22 millimeters and the second distance, third
distance, sixth distance, and seventh distance are equal to one
another and equal to about 1.82 millimeters. While the notch and
projection of each arm have been described as being disposed at
different distances from the second end of the compressible member,
a compressible member can alternatively define a notch and
projection at equal distances from the second end of the
compressible member.
[0043] The first arm 74 is circumferentially adjacent to the second
arm 76 and the fourth arm 80. The second arm 76 is
circumferentially adjacent to the first arm 74 and the third arm
78. The third arm 78 is circumferentially adjacent to the second
arm 76 and the fourth arm 80. The fourth arm 80 is
circumferentially adjacent to the third arm 78 and the first arm
74. As illustrated in FIG. 5A, each of the arms 74, 76, 78, 80 is
separated from a circumferentially adjacent arm a distance 73 when
the compressible member 18 is in the first configuration. In the
illustrated embodiment, the distance 73 between each arm when the
compressible member 18 is in the first configuration is equal to
about 0.6 millimeters and the end of the slot formed between each
arm has a radius of curvature equal to about 0.3 millimeters. The
arms 74, 76, 78, 80 cooperatively define a first outside diameter
75, a second outside diameter 77, and a first inside diameter 79
when the compressible member 18 is in the first configuration. The
first outside diameter 75 is disposed along the length of the
shafts 90 and is measured on a plane that is orthogonal to the
lengthwise axis 63 of the compressible member 18. The second
outside diameter 77 is disposed along the length of the heads 92
and is measured on a plane that is orthogonal to the lengthwise
axis 63 of the compressible member 18. The first outside diameter
75 is less than the second outside diameter 77 and is sized and
configured to be received by the recess 42 defined by the first
member 30. The second outside diameter 77 is greater than the first
outside diameter 75 and is less than the diameter 53 of the first
recess 52 defined by the second member 32 such that the second end
66 of the compressible member 18 is sized and configured to be
received by the first recess 52 defined by the second member 32.
The second outside diameter 77 is greater than the diameter 43 of
the recess 42 defined by the first member 30. The outside diameter
of the compressible member 18 tapers from the second outside
diameter 77 to the first outside diameter 75 along a portion 87 of
the length 67 of the compressible member 18. This structural
configuration provides a mechanism for moving the compressible
member 18 between its first configuration when the first member 30
of the handle 16 is free of the second member 32 of the handle 16
and its second configuration when the first member 30 of the handle
16 is releasably attached to the second member 32 of the handle 16.
The first inside diameter 79 is measured on a plane that is
orthogonal to the lengthwise axis 63 and is sized and configured to
receive a medical device, such as a guidewire, and allow a portion
of the medical device to pass through the passageway 72.
[0044] The arms 74, 76, 78, 80 cooperatively define a third outside
diameter 81, a fourth outside diameter 83, and a second inside
diameter 85 when the compressible member 18 is in the second
configuration, as illustrated in FIGS. 5C and 5D. In use, the
compressible member 18 is in the second configuration when it is
disposed within the handle 16 and the first member 30 is attached
to the second member 32. The third outside diameter 81 is disposed
along the length of the shafts 90 and is measured on a plane that
is orthogonal to the lengthwise axis 63. The fourth outside
diameter 83 is disposed along the length of the heads 92 and is
measured on a plane that is orthogonal to the lengthwise axis 63.
The third outside diameter 81 is less than the first outside
diameter 75. The fourth outside diameter 83 is greater than the
third outside diameter 81 and is less than the second outside
diameter 77. The fourth outside diameter 83 is greater than the
diameter 43 of the recess 42 defined by the first member 30 such
that when the compressible member 18 is in the second configuration
a portion of the head 92 of each arm is disposed outside of the
recess 42 defined by the first member 30. The second inside
diameter 85 is measured on a plane that is orthogonal to the
lengthwise axis 63 and is sized and configured to receive a portion
of a medical device, such as a guidewire, such that the
compressible member 18 contacts the medical device along a portion
of the shafts 90 and/or heads 92 and the medical device is
releasably attached to the compressible member 18 and the handle
16.
[0045] In use, the first end 64 of the compressible member 18 is
partially positioned within the recess 42 defined by the first
member 30 and the second end 66 of the compressible member 18 is
advanced into the first recess 52 defined by the second member 32
of the handle 16. The threads 44 of the first member 30 are mated
with the threads 60 of the second member 32 such that the
application of torque on the first member 30 while the position of
the second member 32 is maintained, or vice versa, advances the
second end 36 of the first member 30 toward the second end 48 of
the second member 32. Alternatively, torque can be applied to both
the first member 30 and the second member 32 such that the second
end 36 of the first member 30 is advanced toward the second end 48
of the second member 32. This results in the handle 16 moving from
the first configuration to the second configuration and the
exterior surface of the tapered portion 87 of the compressible
member 18 contacting the first end 34 of the first member 30 such
that continued advancement of the first member 30 into the second
member 32 moves the compressible member 18 from the first
configuration to the second configuration.
[0046] While the compressible member 18 has been illustrated as a
separate component releasably attached to the handle 16, a portion
of a handle of a rotatable control handle can alternatively form a
compressible member. For example, each arm of a compressible member
can be formed by a first member or second member of a handle and
adapted to move between first and second configurations, as
described herein. In addition, while the compressible member 18 has
been illustrated as having a particular structural configuration
and particular dimensions, a compressible member included in a
rotatable control handle can have any suitable structural
configuration and can have any suitable dimensions. Selection of a
suitable structural configuration and dimensions for a compressible
member can be based on various considerations, such as the
structural configuration of the medical device intended to be used
with the rotatable control handle. For example, a compressible
member can define a curved, rounded, or blunt surface that is
directed toward the lengthwise axis of the compressible member such
that damage to any medical device disposed through a rotatable
control handle can be prevented during use. In addition, while the
compressible member 18 has been illustrated as having a first end
64 disposed within the first member 30 of a handle 16 and a second
end 66 disposed within the second member 32 of a handle 16, a
handle can include structure that allows for a compressible member
to be positioned within the handle in the opposite configuration.
For example, the body of the first member of a handle can define a
recess that extends from the second end toward the first end that
is sized and configured to receive the second end of a compressible
member (e.g., has a structural arrangement that mirrors the first
recess 52 defined by the second member 32) and the body of the
second member of the handle can define a first recess that extends
from the first end toward the second end that is sized and
configured to receive the first end of the compressible member
(e.g., has a structural configuration that mirrors the recess 42
defined by the first member 30). In addition, while the
compressible member 18 has been illustrated as having a first arm
74, a second arm 76, a third arm 78, and a fourth arm 80 and each
arm has been illustrated as defining a triangular prismatic notch
94 and a triangular prismatic projection 96, a compressible member
can include any suitable number of arms and the notch and/or
projection of an arm can have any suitable structural arrangement.
Examples of numbers of arms considered suitable for a compressible
member to define include one, at least one, two, a plurality,
three, four, five, six, and any other number considered suitable
for a particular embodiment. Examples of structural configurations
considered suitable for a notch and/or projection included on an
arm include triangular prisms, rectangular prisms, cubes, partial
cylinders, and any other structural configuration considered
suitable for a particular embodiment. Alternatively, a compressible
member can omit the inclusion of a notch and/or projection on each
arm or one or more arms defined by the compressible member.
[0047] In the illustrated embodiment, the cap 20 is rotatably
attached to the handle 16 and, as illustrated in FIG. 6, has a
lengthwise axis 101, a first end 102, a second end 104, a length
105, and a body 106 that defines an exterior surface 108, a recess
110, a first opening 112, a second opening 114, and a passageway
116. The length 105 extends from the first end 102 to the second
end 104 and is greater than the length of the second recess 54
defined by the second member 32. In the illustrated embodiment, the
length 105 of the cap 20 is equal to about 15.7 millimeters and the
outside diameter of the cap 20 at the first end 102 is equal to
about 11 millimeters. The recess 110 extends into the body 106 of
the cap 20 from the exterior surface 108 toward the lengthwise axis
101 of the cap 20 and is sized and configured to receive a portion
of the projection 56 defined by the second member 32 such that the
cap 20 can be releasably, and rotatably, attached to the handle 16
and the cap 20 can rotate relative to the handle 16.
[0048] The first opening 112 has a first inside diameter 113 and
the second opening 114 has a second inside diameter 115 that is
less than the first inside diameter 113. The first inside diameter
113 is equal to about 8 millimeters and the second opening is equal
to about 3.2 millimeters. The passageway 116 extends from the first
opening 112 to the second opening 114 and has proximal portion 118,
an intermediate portion 120, and a distal portion 122. Each of the
first opening 112, second opening 114, and passageway 116 is sized
and configured to receive the guide member 22 and medical device
(e.g., guidewire), as described in more detail herein. The proximal
portion 118 has a constant inside diameter that is equal to the
first inside diameter 113. The proximal portion 118 has a length
that extends from the first end 102 to the intermediate portion 120
that is equal to about 4 millimeters. The distal portion 122 has a
constant inside diameter that is equal to the second inside
diameter 115. The intermediate portion 120 has a diameter that
tapers from the first inside diameter 113 to the second inside
diameter 115 and from the proximal portion 118 to the distal
portion 122 such that the wall of the intermediate portion 120 is
disposed at angle equal to about 45 degrees relative to the
lengthwise axis 101. In the illustrated embodiment, the distal
portion 122 has a length that is greater than the length of the
proximal portion 118 and the length of the intermediate portion
120.
[0049] Attachment of the cap 20 to the handle 16 can be
accomplished by first inserting the guide member 22 into the
passageway 116 defined by the cap 20, then inserting the cannula 24
into the passageway 142 defined by the guide member 22, contacting
the first end 102 of the cap 20 to the second end 48 of the second
member 32, and applying an axial force on the cap 20 directed
toward the second member 32 until the projection 56 defined by the
second member 32 is disposed within the recess 110 defined by the
cap 20. Alternative embodiments can include a cap that defines a
projection that is sized and configured to be received within a
recess defined by the second member of a housing. The projection
defined by the cap can extend from the exterior surface of the cap
and away from the lengthwise axis of the cap and the recess defined
by the second member can extend from an interior surface of the
second member and away from the lengthwise axis of the second
member.
[0050] While the cap 20 has been illustrated as having a particular
structural configuration and having particular dimensions, a cap
included in a rotatable control handle can have any suitable
structural configuration and can have any suitable dimensions.
Selection of a suitable structural configuration and dimensions for
a cap can be based on various considerations, such as the
structural configuration of a handle included in the rotatable
control handle and/or the material(s) that forms the medical device
on which the rotatable control handle is intended to be disposed.
In addition, while the cap 20 has been illustrated as being
attached to the handle 16 using a snap fit configuration, a cap can
be releasably attached to a handle using any suitable technique or
method of attachment considered suitable for a particular
embodiment. Selection of a suitable technique or method of
attachment between a cap and a handle can be based on various
considerations, such as the material(s) that forms the handle to
which the cap is intended to be attached. Examples of techniques
and methods of attachment considered suitable between a cap and a
handle include snap fit configurations, threaded connections (e.g.,
a second member of the handle defines threads that are sized and
configured to mate with threads defined by a cap), fusing, welding,
using adhesives, and any other technique or method of attachment
considered suitable for a particular embodiment. For example, a cap
can be fixedly attached to a handle (e.g., using adhesive, fusing)
such that it is not rotatable relative to the handle. In this
alternative embodiment, only the cannula is rotatable relative to
the cap and handle or a combination of the cannula and the guide
member is rotatable relative to the cap and the handle.
[0051] As illustrated in FIG. 7, the guide member 22 has a
lengthwise axis 129, a first end 130, a second end 132, a length
133, and a body 134 that defines an exterior surface 136, a first
opening 138, a second opening 140, and a passageway 142. The length
133 extends from the first end 130 to the second end 132 and is
equal to the length 105 of the cap 20. The exterior surface 136 of
the guide member 22 has a structural configuration that corresponds
to the structural configuration of the passageway 116 defined by
the cap 20 such that the guide member 22 can be positioned within
the passageway 116 and attached to the cap 20. The exterior surface
136 of the guide member 22 has a proximal portion 144, an
intermediate portion 146, and a distal portion 148. The proximal
portion 144 has a first outside diameter 145 that is less than the
first inside diameter 113 of the passageway 116. In the illustrated
embodiment, the first outside diameter 145 is equal to about 7.9
millimeters and the length of the proximal portion 144 that extends
from the first end 130 to the intermediate portion 146 is equal to
about 3.9 millimeters. The distal portion 148 has a second outside
diameter 149 that is less than the second inside diameter 115 of
the passageway 116. In the illustrated embodiment, the second
outside diameter 149 is equal to about 3.17 millimeters and the sum
of the length of the intermediate portion 146 and the distal
portion 148 from the proximal portion 144 to the second end 132 is
equal to about 11.7 millimeters. The intermediate portion 146 has
an outside diameter that tapers from the first outside diameter 145
to the second diameter 149 and from the proximal portion 144 to the
distal portion 148. In the illustrated embodiment, the intermediate
portion 146 tapers from the proximal portion 144 to the distal
portion 148 such that the wall of the intermediate portion 146 is
disposed at an angle that is equal to about 45 degrees relative to
the lengthwise axis 129 of the guide member 22.
[0052] The first opening 138 has a first inside diameter 139 and
the second opening 140 has a second inside diameter 141 that is
less than the first inside diameter 139. The passageway 142 extends
from the first opening 138 to the second opening 140 and has
proximal portion 150, a first intermediate portion 152, a second
intermediate portion 154, a third intermediate portion 156, a
fourth intermediate portion 158, and a distal portion 160. Each of
the first opening 138, the second opening 140, and the passageway
142 is sized and configured to receive a portion of the cannula 24
and a medical device, as described in more detail herein. The
proximal portion 150 has a diameter equal to the first inside
diameter 139, the first intermediate portion 152 has a third inside
diameter 153, the second intermediate portion 154 has a diameter
that tapers from the first intermediate portion 152 to the third
intermediate portion 156, the third intermediate portion 156 has a
fourth inside diameter 157, the fourth intermediate portion 158 has
a fifth inside diameter 159, and the distal portion 160 has a
diameter that increases from the fourth intermediate portion 158 to
the second inside diameter 141 at the second end 132 of the guide
member 22. The third inside diameter 153 is greater than the first
inside diameter 139. The fourth inside diameter 157 is less than
the third inside diameter 153 and the fifth inside diameter 159.
The fourth inside diameter 157 is sized and configured to allow the
cannula 24 to be rotatably disposed through the guide member 22 and
the cap 20 and prevent fluid from passing between the guide member
22 and cannula 24 during use.
[0053] In the illustrated embodiment, the first inside diameter 139
is equal to about 4.7 millimeters, the second inside diameter 141
is equal to about 2.2 millimeters, the third inside diameter 153 is
equal to about 6.2 millimeters, the inside diameter of the second
intermediate portion 154 adjacent to the first intermediate portion
152 is equal to about 3.3 millimeters, the fourth inside diameter
157 is equal to about 0.9 millimeters, and the fifth inside
diameter 159 is equal to about 1.2 millimeters. In addition, the
second intermediate portion 154 tapers from the first intermediate
portion 152 to the third intermediate portion 156 such that the
wall of the second intermediate portion 154 is disposed at an angle
equal to about 30 degrees relative to the lengthwise axis 129.
Furthermore, the distal portion 160 increases in diameter from the
fourth intermediate portion 158 to the second end 132 such that the
wall of the distal portion 160 is disposed at an angle equal to
about 30 degrees relative to the lengthwise axis 129. The sum of
the lengths of the proximal portion 150 and the first intermediate
portion 152 from the first end 130 to the second intermediate
portion 154 is equal to about 3.2 millimeters. The length of the
first intermediate portion 152 from the proximal portion 150 to the
second intermediate portion 154 is equal to about 2 millimeters.
The sum of the lengths of the fourth intermediate portion 158 and
the distal portion 160 from the third intermediate portion 156 to
the second end 132 is equal to about 9.7 millimeters.
[0054] In the illustrated embodiment, the guide member 22 is
adhesively attached to the cap 20. However, alternative techniques
and methods of attachment can be used to attach a guide member to a
cap. Examples of techniques and methods of attachment considered
suitable between a guide member and a cap included using adhesives,
threaded connections, friction fit connections, fusing a portion of
the guide member to the cap, forming the guide member as a portion
of a cap, snap fit configurations, and any other technique or
method of attachment considered suitable for a particular
embodiment. For example, alternative embodiments can include a
guide member that is rotatably attached to a cap. While the guide
member 22 has been illustrated as having a particular structural
configuration and having particular dimensions, a guide member
included in a rotatable control handle can have any suitable
structural configuration and can have any suitable dimensions.
Selection of a suitable structural configuration and dimensions for
a guide member can be based on various considerations, such as the
structural configuration of a cap included in the rotatable control
handle and/or the material(s) that forms the medical device on
which the rotatable control handle is intended to be disposed.
Alternative embodiments can omit the inclusion of a guide member
and a cap can define structure that is sized and configured to
correspond with a portion of the structure of a cannula.
[0055] While the guide member 22 has been illustrated as having a
proximal portion 144 that has a first outside diameter 145 that is
less than the first inside diameter 113 of the passageway 116
defined by the cap 20 and a distal portion 148 that has a second
outside diameter 149 that is less than the second inside diameter
115 of the passageway 116 defined by the cap 20, a guide member can
have any suitable structural arrangement. For example, a guide
member can have a proximal portion that has a first outside
diameter that is equal to, or greater than, the first inside
diameter of the passageway defined by a cap and/or a distal portion
that has a second outside diameter that is equal to, or greater
than, the second inside diameter of the passageway defined by a cap
such that the guide member can be attached to the cap using a
friction fit.
[0056] As illustrated in FIG. 8, the cannula 24 has a lengthwise
axis 165, a first end 166, a second end 168, a length 169, and a
body 170 that defines an exterior surface 172, a first opening 174,
a second opening 176, and a passageway 178. The length 169 extends
from the first end 166 to the second end 168 and is sized and
configured to pass through a portion of the guide member 22, cap
20, and through a medical device, such as a valve device (e.g.,
hemostatic valve, introducer). A portion of the exterior surface
172 of the cannula 24 has a structural configuration that
corresponds to a portion of the structural configuration of the
passageway 142 defined by the guide member 22 such that the cannula
24 can be positioned, and rotate, within the guide member 22. The
exterior surface 172 of the cannula 24 has a proximal portion 180
and a distal portion 182. The proximal portion 180 has a first
outside diameter 181 that is greater than the fourth inside
diameter 157 of the passageway 142 defined by the guide member 22.
The distal portion 182 has a second outside diameter 183 that is
less than the first outside diameter 181 and is sized and
configured to be passed through the third intermediate portion 156
of the passageway 142 defined by the guide member 22. Thus, the
second outside diameter 183 is less than the fourth inside diameter
157. This structural arrangement provides a mechanism for passing
the cannula 24 through the passageway 142 defined by the guide
member 22 until the exterior surface 172 of the cannula 24 along
the proximal portion 180 contacts the interior surface of the guide
member 22 along the second intermediate portion 154. Alternatively,
the second outside diameter of a cannula can be equal to the fourth
inside diameter of a guide member such that a friction fit between
the cannula and guide member can be accomplished.
[0057] The first opening 174 has a first inside diameter 175 and
the second opening 176 has a second inside diameter 177 that is
less than the first inside diameter 175. The passageway 178 extends
from the first opening 174 to the second opening 176 and has
proximal portion 184 and a distal portion 186. Each of the first
opening 174, second opening 176, and passageway 178 is sized and
configured to receive a portion of a medical device, such as a
guidewire. The inside diameter of the proximal portion 184 tapers
from the first inside diameter 175 at the first opening 174 to the
second inside diameter 177 along a portion of the length 169 of the
cannula 24.
[0058] In the illustrated embodiment, when assembled, as
illustrated in FIG. 1, the length of the rotatable control handle
10 from the first end 12 to the second end 14 is equal to about 9
centimeters. In addition, the cap 20 is rotatable relative to the
handle 16 and the cannula 24 is rotatable relative to the cap 20
and the handle 16. This arrangement provides a mechanism for
allowing a first medical device, such as a guidewire, that has been
passed through and attached to the rotatable control handle 10, to
be passed through a second medical device, such as a valve device
(e.g., hemostatic valve, introducer), such that the first medical
device can be rotated relative to the second medical device during
use. For example, when delivering an embolization coil, a delivery
system that includes a guidewire on which the embolization coil is
attached can be attached to the rotatable control handle 10 such
that the rotatable control handle 10 is attached to the guidewire
between the embolization coil and the proximal end of the
guidewire. Subsequently, the rotatable control handle 10 and the
attached guidewire can be advanced through a valve device such that
the cannula 24 of the rotatable control handle 10 contacts a
portion of a valve member attached to the valve device and is
partially disposed through the valve member. The handle 16 and
guidewire can then be rotated relative to the valve device since
the friction applied by the valve member on the cannula 24 of the
rotatable control handle 10 maintains the position of the cannula
24. Depending on the structural configuration of a rotatable
control handle, a cap and cannula can rotate relative to the valve
device during use (e.g., in embodiments in which the guide member
and/or cap are attached (e.g., soldered) to a cannula).
[0059] In use, the rotatable control handle 10 is positioned on a
medical device and attached to the medical device such that the
rotatable control handle provides a mechanism for manipulating the
position of the medical device during use. The rotatable control
handles described herein can be used in combination with, and
attached to, any suitable medical device and selection of a
suitable medical device to use in combination with a rotatable
control handle can be based on various considerations, such as the
procedure intended to be performed by the medical device. For
example, a rotatable control handle according to an embodiment can
be attached to a guidewire, embolization device, probe, lithotripsy
probe, delivery device, delivery systems that include a guidewire
with an attached embolization coil, embolization coil delivery
device, an optic, fiber optic, fiber, laser fiber, suction device,
irrigation device, basket, stone basket, grasper, forceps, grasping
forceps, drill, catheter, balloon catheter, and any other medical
device considered suitable for a particular embodiment.
[0060] Each of the handle 16 (e.g., first member 30, second member
32), compressible member 18, cap 20, guide member 22, and cannula
24 can be formed of any suitable material and can be fabricated
using any suitable method or technique. Selection of a suitable
material to form a handle, compressible member, cap, guide member,
and/or cannula and a suitable method or technique to fabricate a
handle, compressible member, cap, guide member, and/or cannula
according to a particular embodiment can be based on various
considerations, including the material(s) that forms a medical
device that is intended to be used with a rotatable control handle
of which the handle, compressible member, cap, guide member, and/or
cannula is a component. Examples of materials considered suitable
to form a handle, compressible member, cap, guide member, and/or
cannula include biocompatible materials, materials that can be made
biocompatible, metals such as stainless steel, titanium, brass,
nickel-titanium alloys (e.g., Nitinol), polymers, Pebax (Pebax is a
registered trademark of AtoChimie Corporation of Allee des Vosges,
Courbevoie, France), nylon, polyethylene, polyurethane, silicone,
combinations of the materials described herein, and any other
material considered suitable for a particular application. Examples
of methods and techniques considered suitable to fabricate a
handle, compressible member, cap, guide member, and/or cannula
include extrusion processes, molding processes, injection molding
processes, casting processes, and any other method or technique
considered suitable for a particular embodiment.
[0061] In the illustrated embodiment, each of the handle 16 (e.g.,
first member 30, second member 32), the cap 20, and the guide
member 22 is formed of a polymer and each of the compressible
member 18 and cannula 25 is formed of a metal. However, in
alternative embodiments, a handle can be formed of a first material
(e.g., metal) and a compressible member can be entirely formed, or
partially formed, of a second material (e.g., polymer) such that
the compressible member is relatively more flexible than the
handle. This alternative arrangement provides a mechanism for
preventing damage to a medical device (e.g., guidewire) that is
disposed through the compressible member and the handle.
[0062] FIG. 9 illustrates an alternative compressible member 218
suitable for use in a rotatable control handle according to an
embodiment. The compressible member 218 is similar to the
compressible member 18 illustrated in FIGS. 1, 2, 3, 5, 5A, 5B, 5C,
and 5D, and described above, except as detailed below. The
compressible member 218 has a lengthwise axis 263, a first end 264,
a second end 266, a length 267, and a body 268 that defines a base
270, a passageway 272, a first arm 274, a second arm 276, and a
third arm 278.
[0063] In the illustrated embodiment, the base 270 is formed of a
first material and each of the first arm 274, second arm 276, and
third arm 278 is formed of a second material that is different than
the first material. The second material is relatively more flexible
than the first material such that damage to a medical device
disposed through the compressible member 218 is prevented during
use. Alternative to, or in combination with, forming each of the
arms of a compressible member of a material that is different than
the material that forms the base of the compressible member, a
compressible member, such as one that is entirely formed of the
same material, can include a localized coating on each of the arms
that is disposed on a surface that is directed toward the
lengthwise axis of the compressible member (e.g., surfaces that are
intended to contact a medical device, such as a guidewire). For
example, the coating can be disposed on each arm on any surface
that contacts a medical device positioned through the compressible
member when the compressible member is in the second configuration.
The coating can be formed of a material that is different than the
material that forms the compressible member and be relatively more
flexible than the material that forms the compressible member.
Examples of materials considered suitable to form a coating include
polymers, rubber, metals, alloys, and any other material considered
suitable for a particular embodiment.
[0064] FIG. 10 illustrates an alternative cap 420 suitable for use
in a rotatable control handle according to an embodiment. The cap
420 is similar to the cap 20 illustrated in FIGS. 1, 2, 3, and 6,
and described above, except as detailed below. In the illustrated
embodiment, the cap 420 forms a structural configuration similar to
the guide member 22, illustrated in FIGS. 1, 2, 3, and 7, and
described above. The cap 420 comprises a lengthwise axis 501, a
first end 502, a second end 504, a length 505, and a body 506 that
defines an exterior surface 508, a first opening 538, a second
opening 540, and a passageway 542.
[0065] In the illustrated embodiment, the cap 420 omits the
inclusion of a recess (e.g., 110) and can be fixedly attached to a
handle using an adhesive. The first opening 538 has a first inside
diameter 539 and the second opening 540 has a second inside
diameter 541 that is less than the first inside diameter 539. The
passageway 542 extends from the first opening 538 to the second
opening 540 and has proximal portion 550, a first intermediate
portion 552, a second intermediate portion 554, a third
intermediate portion 556, a fourth intermediate portion 558, and a
distal portion 560. Each of the first opening 538, the second
opening 540, and the passageway 542 is sized and configured to
receive a portion of a cannula and a medical device, such as a
guidewire, as described in more detail herein. The proximal portion
550 has a diameter equal to the first inside diameter 539, the
first intermediate portion 552 has a third inside diameter 553, the
second intermediate portion 554 has a diameter that tapers from the
first intermediate portion 552 to the third intermediate portion
556, the third intermediate portion 556 has a fourth inside
diameter 557, the fourth intermediate portion 558 has a fifth
inside diameter 559, and the distal portion 560 has a diameter that
increases from the fourth intermediate portion 558 to the second
inside diameter 541 at the second end 504 of the cap 420. The third
inside diameter 553 is greater than the first inside diameter 539.
The fourth inside diameter 557 is less than the third inside
diameter 553 and the fifth inside diameter 559. The fourth inside
diameter 557 is sized and configured to allow a cannula to be
passed through the cap 420 such that it is rotatably attached to
the cap 420.
[0066] Methods of using a rotatable control handle are described
herein. While the methods described herein are shown and described
as a series of acts, it is to be understood and appreciated that
the methods are not limited by the order of acts described and
illustrated, as some acts may in accordance with these methods, be
omitted, be repeated, or occur in different orders and/or
concurrently with other acts described herein. While some steps,
optional steps, and/or alternative steps are exemplified by using a
rotatable control handle on a guidewire, the methods, steps,
optional steps, and/or alternative steps described herein can be
used on any suitable medical device and to perform any suitable
method of using a rotatable control handle, or method of treatment.
Selection of a suitable structure on which to use a rotatable
control handle according to an embodiment and perform the methods,
steps, optional steps, and/or alternative steps described herein
can be based on various considerations, such as the method of using
a rotatable control handle, or method of treatment, intended to be
performed.
[0067] FIG. 11 is a schematic illustration of an example method 600
of using a rotatable control handle.
[0068] A step 602 comprises moving the handle of a rotatable
control handle from a second configuration to a first
configuration. Another step 604 comprises positioning the rotatable
control handle on a medical device. The medical device comprises a
first end, a second end, and a length that extends from the first
end to the second end. Another step 606 comprises positioning the
rotatable control handle at a predetermined location on the medical
device. Another step 608 comprises moving the handle of the
rotatable control handle from a first configuration to a second
configuration. Another step 610 comprises applying an axial force
on the rotatable control handle directed toward a valve device such
that the medical device is advanced through a valve member of the
valve device and the first end of the medical device is disposed on
a first side of the valve member and the second end of the medical
device is disposed on a second side of the valve member. The valve
device comprises a housing, a valve member, and a sheath. Another
step 612 comprises continuing the application of an axial force on
the rotatable control handle such that the rotatable control handle
and the medical device are advanced through the valve member of the
valve device and the first end of the cannula is disposed on the
second side of the valve member and the second end of the cannula
is disposed on the first side of the valve member. Another step 614
comprises applying torque to the handle of the rotatable control
handle such that the handle and medical device rotate relative to
the valve device. Another step 616 comprises moving the handle of
the rotatable control handle from a second configuration to a first
configuration. Another step 618 comprises applying axial force on
the medical device such that the medical device moves relative to
the handle. Another step 620 comprises moving the handle of the
rotatable control handle from a first configuration to a second
configuration. Another step 622 comprises applying an axial force
on the rotatable control handle directed away from the valve device
such that the rotatable control handle and the medical device are
withdrawn from the valve member of the valve device, the second end
of the cannula is disposed on the second side of the valve member,
and the medical device and rotatable control handle are free of the
valve device. Another step 624 comprises moving the handle of the
rotatable control handle from the second configuration to the first
configuration. Another step 626 comprises withdrawing the medical
device from the first member and the second member of the handle of
the rotatable control handle.
[0069] Step 602 can be accomplished using any suitable rotatable
control handle according to an embodiment, such as rotatable
control handle 10, variations thereof, and any other rotatable
control handle considered suitable for a particular method of using
a rotatable control handle or method of treatment. An example
rotatable control handle that can be used to accomplish the
methods, steps, alternative steps, and/or optional steps described
herein is illustrated and described with respect to FIGS. 1, 2, 3,
4, 5, 5A, 5B, 5C, 5D, 6, 7, and 8, and comprises a handle 16, a
compressible member 18, a cap 20, a guide member 22, and a cannula
24.
[0070] Step 602 can be accomplished by applying torque on the first
member 30 while maintaining the position of the second member 32
such that the second end 36 of the first member 30 advances away
from the second end 48 of the second member 32, the first member 30
becomes free of the second member 32, and the compressible member
18 moves from the second configuration to the first configuration.
Alternatively, step 602 can be accomplished by applying torque on
the first member 30 while maintaining the position of the second
member 32 until the second end 36 of the first member 30 advances
away from the second end 48 of the second member 32 and the
compressible member 18 moves from the second configuration to the
first configuration while the first member 30 and second member 32
are still in contact with one another. For example, in the second
configuration the first member first end is disposed a first
distance from the second member second end and in the first
configuration the first member first end first end is disposed a
second distance from the second member second end that is greater
than the first distance. Alternatively, step 602 can be
accomplished by applying torque on the second member 32 while
maintaining the position of the first member 30 such that the
second end 48 of the second member 32 advances away from the second
end 36 of the first member 30, the first member 30 becomes free of
the second member 32, and the compressible member 18 moves from the
second configuration to the first configuration. Alternatively,
step 602 can be accomplished by applying torque on the second
member 32 while maintaining the position of the first member 30
until the second end 48 of the second member 32 advances away from
the second end 36 of the first member 30 and the compressible
member 18 moves from the second configuration to the first
configuration while the first member 30 and second member 32 are
still in contact with one another. Alternatively, step 602 can be
accomplished by applying torque on the second member 32 while
concurrently applying torque on the first member 30 such that the
second end 48 of the second member 32 advances away from the second
end 36 of the first member 30, the first member 30 becomes free of
the second member 32, and the compressible member 18 moves from the
second configuration to the first configuration. Alternatively,
step 602 can be accomplished by applying torque on the second
member 32 while concurrently applying torque on the first member 30
until the second end 48 of the second member 32 advances away from
the second end 36 of the first member 30 and the compressible
member 18 moves from the second configuration to the first
configuration while the first member 30 and second member 32 are
still in contact with one another. Alternatively, step 602 can be
omitted from method 600 if the rotatable control handle 10 is
provided in the first configuration.
[0071] Step 604 can be accomplished by positioning the rotatable
control handle 10 on any suitable medical device and selection of a
suitable medical device to use in combination with a rotatable
control handle can be based on various considerations, such as the
method of using a rotatable control handle or method of treatment
intended to be performed. Example medical devices on which it is
considered suitable to position a rotatable control handle include
guidewires, embolization devices, probes, lithotripsy probes,
delivery devices, delivery systems that include a guidewire with an
attached embolization coil, optics, fiber optics, fibers, laser
fibers, suction devices, irrigation devices, baskets, stone
baskets, graspers, forceps, grasping forceps, drills, catheters,
balloon catheters, and any other device considered suitable for a
particular application. It is considered advantageous to position a
rotatable control handle on a medical device at least because it
provides a mechanism for providing fine motor control over the
medical device, it provides a mechanical stop to the distal
advancement of the medical device through a second medical device
(e.g., valve device, hemostatic valve), and provides a mechanism
for manipulating the medical device through a second medical device
(e.g., valve device, hemostatic valve) through which it is
disposed. For example, if a medical device 702 is advanced through
a valve device 704, as shown in FIGS. 12 and 13, the cannula 24 of
the rotatable control handle 10 will contact the valve member 708
of the valve device 704 instead of the medical device 702 to
prevent damage (e.g., kinking) to the medical device 702 during use
and increase the maneuverability of the medical device 702 through
the valve member 708. When the method 600 of using a rotatable
control handle is being performed as part of a method of treatment,
it is considered advantageous to position a rotatable control
handle on a medical device at least because it provides a mechanism
for providing fine motor control over the medical device, it
provides a mechanical stop to the distal advancement of the medical
device within a bodily passage, and provides a mechanism for
manipulating the medical device through a second medical device
(e.g., valve device, hemostatic valve) through which it is
disposed. In embodiments in which a rotatable control handle is
positioned on a guidewire, the rotatable control handle can be
positioned on any suitable guidewire, formed of any suitable
material and having any suitable structural arrangement, and
selection of a suitable guidewire can be based on various
considerations, such as the treatment intended to be performed.
Examples of materials considered suitable to form a guidewire
disposed through a rotatable control handle include guidewires that
are formed of biocompatible materials, materials that can be made
biocompatible, metals such as stainless steel, titanium, brass,
nickel-titanium alloys (e.g., Nitinol), polymers, Pebax, nylon,
polyethylene, polyurethane, silicone, combinations of the materials
described herein, and any other material considered suitable for a
particular embodiment.
[0072] Step 604 can be accomplished by applying an axial force on a
medical device directed toward the rotatable control handle 10
while maintaining the position of the handle 16 such that the first
end or second end of the medical device is advanced through the
passageway 40 and recess 42 defined by the first member 30, the
passageway 72 defined by compressible member 18, between the arms
74, 76, 78, 80 of the compressible member 18, the first recess 52,
second recess 54, and passageway 58 defined by the second member
32, the passageway 142 defined by the guide member 22, and the
passageway 178 defined by the cannula 24. Alternatively, step 604
can be accomplished by maintaining the position of the medical
device and applying an axial force on the first member 30 and
second member 32 of the rotatable control handle 10 directed toward
the medical device such that the first end or second end of the
medical device is advanced through the passageway 40 and recess 42
defined by the first member 30, the passageway 72 defined by the
compressible member 18, between the arms 74, 76, 78, 80 of the
compressible member 18, the first recess 52, second recess 54, and
passageway 58 defined by the second member 32, the passageway 142
defined by the guide member 22, and the passageway 178 defined by
the cannula 24. Alternatively, in embodiments that omit the
inclusion of a guide member, the medical device is passed through
the passageway defined by a cap and into the passageway defined by
the cannula.
[0073] Step 606 can be accomplished based upon various measured
factors, and selection of a suitable measurement to base the
positioning of a rotatable control handle on a medical device
according to a particular embodiment can be based on various
considerations, including the method of using a rotatable control
handle intended to be performed. Examples of measurements
considered suitable to base the positioning of a rotatable control
handle on a medical device include the structural arrangement of a
second medical device (e.g., valve device, hemostatic valve), an
estimate as to the length of the medical device desired to be
passed through a second medical device (e.g., valve device,
hemostatic valve), and any other measurement considered suitable
for a particular application. Alternatively, a rotatable control
handle can be positioned on a medical device at any suitable
location between the first end and the second end of the medical
device. When the method 600 of using a rotatable control handle is
being performed as part of a method of treatment, step 606 can
alternatively be accomplished based upon various measured and/or
physiological factors, and selection of a suitable measurement
and/or physiological factor to base the positioning of a rotatable
control handle on a medical device according to a particular
embodiment can be based on various considerations, including the
treatment intended to be performed. Examples of measurements and/or
physiological factors considered suitable to base the positioning
of a rotatable control handle on a medical device when performing a
method of treatment include the structural arrangement of a bodily
passage, an estimate as to the length of the medical device desired
to be introduced into a bodily passage, the location of a point of
treatment within a bodily passage, a previously determined
measurement (e.g., the location desired to place an embolization
coil within a bodily passage), and any other measurement and/or
physiological factor considered suitable for a particular
application. Alternative embodiments can omit the inclusion of step
606.
[0074] Step 608 can be accomplished by applying torque on the first
member 30 while maintaining the position of the second member 32
such that the second end 36 of the first member 30 advances toward
the second end 48 of the second member 32, the first member 30
becomes releasably attached to the second member 32, and the
compressible member 18 moves from the first configuration to the
second configuration. For example, in the first configuration the
first member first end is disposed a first distance from the second
member second end and in the second configuration the first member
first end first end is disposed a second distance from the second
member second end that is less than the first distance and the
first member is releasably attached to the second member.
Alternatively, step 608 can be accomplished by applying torque on
the second member 32 while maintaining the position of the first
member 30 such that the second end 48 of the second member 32
advances toward the second end 36 of the first member 30, the first
member 30 becomes releasably attached to the second member 32, and
the compressible member 18 moves from the first configuration to
the second configuration. Alternatively, step 608 can be
accomplished by applying torque on the first member 30 while
concurrently applying torque on the second member 32 such that the
second end 48 of the second member 32 advances toward the second
end 36 of the first member 30, the first member 30 becomes
releasably attached to the second member 32, and the compressible
member 18 moves from the first configuration to the second
configuration.
[0075] Step 610 can be accomplished by applying an axial force on
any suitable portion of the rotatable control handle 10 (e.g.,
handle 16) directed toward the valve device such that the medical
device is advanced through the valve member. FIG. 12 illustrates a
guidewire 702 positioned through a valve device 704 that has a
housing 706, a valve member 708, and a sheath 710 such that the
first end of the guidewire 702 is disposed on a first side 712 of
the valve member 708 and the second end of the guidewire 702 is
disposed on a second side 714 of the valve member 708. In
embodiments in which the first end of the guidewire is disposed
within the passageway 178 defined by the cannula 24, step 610 can
be omitted from method 600.
[0076] Alternatively, step 610 can comprise applying an axial force
on the medical device directed toward a valve device such that the
medical device is advanced through the valve member of the valve
device and the first end of the medical device is disposed on a
first side of the valve member and the second end of the medical
device is disposed on a second side of the valve member. This
alternative step can be accomplished by applying an axial force on
any suitable portion of the medical device directed toward the
valve device such that the medical device is advanced through the
valve member. During performance of method 600, the sheath of the
valve device can optionally be free of any other device or
partially disposed within a third medical device (e.g., model of a
bodily passage, such as a model of a venous valve).
[0077] While method 600 has been described as a method of using a
rotatable control handle, method 600, and the alternative steps
and/or optional steps described with respect to method 600, can be
accomplished as part of any suitable method that uses a rotatable
control handle. For example, method 600, and the alternative steps
and/or optional steps described with respect to method 600, can
alternatively be used as a method of treatment, or as part of a
method of treatment, as a method of demonstrating use of a
rotatable control handle, or as part of a method of demonstrating
use of a rotatable control handle, as a method of controlling a
medical device, or as part of a method of controlling a medical
device, as a method of positioning a medical device (e.g.,
guidewire) within a rotatable control handle, or as part of a
method of positioning a medical device (e.g., guidewire) within a
rotatable control handle. When the method 600 is being performed as
part of a method of treatment, the sheath of the valve device can
optionally be partially disposed within a bodily passage or can be
entirely disposed outside of a bodily passage. When the method 600
is being performed as part of a method of treatment, optional steps
that can be completed comprise creating a surgical opening in a
bodily passage (e.g., body vessel) using a needle; applying an
axial force on a guidewire directed toward the needle such that the
guidewire is passed through a bore of the needle and is partially
disposed within the bodily passage; applying an axial force on a
valve device directed toward the guidewire such that the valve
device is advanced over the guidewire and is partially disposed
within the bodily passage, the valve device has a housing, a valve
member, a sheath, and a dilator; applying an axial force on the
dilator directed away from the bodily passage such that the dilator
is removed from the valve device and is free of the guidewire;
applying an axial force directed toward a bodily passage on any
suitable portion of a valve device such that the sheath is
partially disposed within the bodily passage; and/or applying an
axial force on the guidewire directed away from the bodily passage
such that the guidewire is removed from the valve device and is
free of the bodily passage. When the method 600 is being performed
as part of a method of treatment, the steps, alternative steps,
and/or optional steps described herein can be accomplished with
respect to treating any suitable condition within any suitable
bodily passage including, but not limited to, a salivary duct, the
urinary tract, a portion of the vascular system, an artery, a vein,
and any other bodily passage considered suitable for a particular
application.
[0078] Step 612 can be accomplished by applying an axial force on
any suitable portion of the rotatable control handle 10 (e.g.,
handle 16) directed toward the valve device such that the cannula
24 is advanced through the valve member. FIG. 13 illustrates the
cannula 24 of a rotatable control handle 10 positioned through a
valve device 704 that has a housing 706, a valve member 708, and a
sheath 710 such that the second end 168 of the cannula 24 is
disposed on the first side 712 of the valve member 708 and the
first end 166 of the cannula 24 is disposed on the second side 714
of the valve member 708. Alternatively, when method 600 is being
performed as a method of treatment, step 612 can comprise
continuing the application of an axial force on the rotatable
control handle such that the rotatable control handle and the
medical device are advanced through the valve member of the valve
device, the first end of the cannula is disposed on the second side
of the valve member, the second end of the cannula is disposed on
the first side of the valve member, and the second end of the
medical device is disposed at a point of treatment (e.g., the
desired location to deliver an embolization coil).
[0079] Step 614 can be accomplished by applying a torque on any
suitable portion of the rotatable control handle 10 (e.g., handle
16) in a clockwise or counterclockwise direction such that the
handle 16 and medical device rotate relative to the valve device.
As illustrated in FIG. 13, the application of a force in the
counterclockwise direction, as illustrated by arrows 722, will
result in rotation of the guidewire 702 and the handle 16 in a
counterclockwise direction. Since the cannula 24 is disposed
through the valve member 708 of the valve device 704, the position
of the cannula 24 will be fixed, or substantially fixed, during
rotational movement of the handle 16 and guidewire 702. Optionally,
depending on the method of using a rotatable control handle being
performed, step 614 can be omitted from method 600. For example,
when the method 600 is being performed as part of a method of
treatment, the medical device on which the rotatable control is
disposed can comprise a delivery system that includes a guidewire
with an attached embolization coil disposed on the second end of
the guidewire and an optional step that can be included in the
method of treatment comprises continuing the application of torque
on the handle until the embolization coil has been delivered at a
point of treatment. This optional step can be accomplished as
described with respect to step 614. Also, when method 600 is being
performed as a method of treatment, another optional step comprises
confirming placement of the embolization coil. This optional step
can be accomplished using any suitable visualization technique or
method, such as x-ray, fluoroscopy, and any other visualization
technique or method considered suitable for a particular
embodiment.
[0080] Step 616 can be accomplished as described herein with
respect to step 602. Optionally, step 616 can be accomplished while
the cannula 24 is disposed through the valve member of a valve
device.
[0081] Step 618 can be accomplished by applying an axial force on
any suitable portion of the medical device directed toward, or away
from, the valve device such that the medical device is advanced
through, or partially withdrawn from, the valve member. When method
600 is being performed as a method of treatment, an optional step
comprises continuing the application of an axial force on the
medical device until the second end of the medical device is
disposed at a point of treatment. This optional step can be
accomplished by applying an axial force on any suitable portion of
the medical device directed toward, or away from, the valve device
such that the medical device is advanced through, or partially
withdrawn from, the valve member and the second end is advanced
toward, or positioned at, a point of treatment. Optionally, step
618, and the optional step described above, can be accomplished
while the cannula 24 is disposed through the valve member of a
valve device. It is considered advantageous to advance, withdraw,
and rotate a medical device, such as a guidewire, that is disposed
through the valve member of a valve device, or other medical
device, through a rotatable control handle that is in contact with
the valve member to prevent kinking of the medical device and
provide a mechanism to reduce the force required to advance,
withdraw, and rotate the medical device. For example, when using a
rotatable control handle, a medical device, such as a guidewire,
can be advanced, withdrawn, and rotated within a second medical
device, such as a valve device, using only one hand.
[0082] Step 620 can be accomplished as described herein with
respect to step 608. Optionally, step 620 can be accomplished while
the cannula 24 is disposed within the valve member.
[0083] Alternatively, depending on the method of using a rotatable
control handle being performed, each of step 616, step 618, and/or
step 620 can be omitted from method 600 or repeated. For example,
when method 600 is being performed as a method of treatment, each
of step 616, 618, and/or step 620 can be omitted from method 600 or
repeated.
[0084] Step 622 can be accomplished by applying an axial force on
any suitable portion of the rotatable control handle 10 (e.g.,
handle 16) directed away from the valve device such that the
medical device is withdrawn from the valve member. Alternatively,
step 622 can comprise applying an axial force on the medical device
directed away from the valve device such that the rotatable control
handle and medical device are withdrawn from the valve member of
the valve device, the second end of the cannula is disposed on the
second side of the valve member, and the medical device and
rotatable control handle are free of the valve device. This
alternative step can be accomplished by applying an axial force on
any suitable portion of the medical device directed away from the
valve device such that the medical device and rotatable control
handle are withdrawn from the valve member.
[0085] Step 624 can be accomplished as described herein with
respect to step 602. Optionally, step 624 can be omitted from
method 600.
[0086] Step 626 can be accomplished by applying an axial force on
the medical device directed away from the rotatable control handle
10 while maintaining the position of the handle 16 such that the
first end or second end of the medical device is withdrawn from the
passageway 40 and recess 42 defined by the first member 30, the
passageway 72 defined by the compressible member 18, between the
arms 74, 76, 78, 80 of the compressible member 18, the first recess
52, second recess 54, and passageway 58 defined by the second
member 32, the passageway 142 defined by the guide member 22, and
the passageway 178 defined by the cannula 24. Alternatively, step
626 can be accomplished by maintaining the position of the medical
device and applying an axial force on the first member 30 and
second member 32 of the rotatable control handle 10 directed away
from the medical device such that the first end or second end of
the medical device is advanced through the passageway 40 and recess
42 defined by the first member 30, the passageway 72 defined by the
compressible member 18, between the arms 74, 76, 78, 80 of the
compressible member 18, the first recess 52, second recess 54, and
passageway 58 defined by the second member 32, the passageway 142
defined by the guide member 22, and the passageway 178 defined by
the cannula 24. Alternatively, in embodiments that omit the
inclusion of a guide member, the medical device is passed through
the passageway defined by a cap and into the passageway defined by
the cannula. Optionally, step 626 can be omitted from method
600.
[0087] While step 602, step 608, step 616, step 620, and step 624
have been described as being accomplished by applying torque to a
portion of a handle, depending on the structural arrangement of a
handle of a rotatable control handle, each of these steps can be
accomplished by applying an axial force on a portion of a rotatable
control handle. For example, in embodiments in which the first
member of a handle is releasably attachable to a second member
using a snap fit attachment, step 602, step 616, and step 624 can
be accomplished by applying an axial force on the first member
directed away from the second member while maintaining the position
of the second member until the first member is free of attachment
to the second member. Alternatively, in embodiments in which the
first member of a handle is releasably attachable to a second
member using a snap fit attachment, step 602, step 616, and step
624 can be accomplished by applying an axial force on the second
member directed away from the first member while maintaining the
position of the first member until the first member is free of
attachment to the second member. Alternatively, in embodiments in
which the first member of a handle is releasably attachable to a
second member using a snap fit attachment, step 602, step 616, and
step 624 can be accomplished by applying an axial force on the
first member directed away from the second member while
concurrently applying an axial force on the second member directed
away from the first member until the first member is free of
attachment to the second member.
[0088] In embodiments in which the first member of a handle is
releasably attachable to a second member using a snap fit
attachment, step 608 and step 620 can be accomplished by applying
an axial force on the first member directed toward the second
member while maintaining the position of the second member until
the first member is releasably attached to the second member.
Alternatively, in embodiments in which the first member of a handle
is releasably attachable to a second member using a snap fit
attachment, step 608 and step 620 can be accomplished by applying
an axial force on the second member directed toward the first
member while maintaining the position of the first member until the
first member is releasably attached to the second member.
Alternatively, in embodiments in which the first member of a handle
is releasably attachable to a second member using a snap fit
attachment, step 608 and step 620 can be accomplished by applying
an axial force on the second member directed toward the first
member while concurrently applying an axial force on the first
member directed toward the second member until the first member is
releasably attached to the second member.
[0089] FIGS. 14 and 15 illustrate an alternative compressible
member 818 suitable for use in a rotatable control handle according
to an embodiment. The compressible member 818 is similar to the
compressible member 18 illustrated in FIGS. 1, 2, 3, 5, 5A, 5B, 5C,
and 5D, and described above, except as detailed below. The
compressible member 818 has a lengthwise axis 863, a first end 864,
a second end 866, a length 867, and a body 868 that defines a base
870, a passageway 872, a first arm 874, a second arm 876, a third
arm 878, and a fourth arm 880.
[0090] In the illustrated embodiment, the body 868 of the
compressible member 818 defines a continuous surface 894 on the
head 892 of each of the arms 874, 876, 878, 880 (e.g., each arm
omits a recess and projection), a conical recess 896, and the
compressible member 818 includes a inner tubular member 1010 that
is formed of a material that is different than the material that
forms the compressible member 818. The conical recess 896 extends
from the first end 864 toward the second end 866 and provides a
mechanism for directing any medical device passed through the
compressible member 818 into passageway 872.
[0091] The inner tubular member 1010 is partially disposed within
the passageway 872 defined by the compressible member 818 and is
attached to the compressible member 818 using an adhesive. The
inner tubular member 1010 has a first end 1012, a second end 1014,
a length 1013 that extends from the first end 1012 to the second
end 1014, an outside diameter 1015, and a body 1016 that defines a
first notch 1018 and a second notch 1020. The length 1013 of the
inner tubular member 1010 is less than the length 867 of the
compressible member 818 and the inner tubular member 1010 is
partially disposed within passageway 872 such that the first end
1012 is disposed within passageway 872 and the second end 1014 is
disposed outside of passageway 872. Each of the notches 1018, 1020
extends from the second end 1014 of the inner tubular member 1010
toward the first end 1012 of the inner tubular member 1010. Each of
the notches 1018, 1020 has a width 1019 that is less than the
radius of the inner tubular member 1010 and provides a mechanism
from moving the inner tubular member 1010 between a first
configuration and a second configuration. The inner tubular member
1010 is in the first configuration when the compressible member 818
is in the first configuration and the inner tubular member 1010 is
in the second configuration when the compressible member 818 is in
the second configuration. In the first configuration, the inner
tubular member 1010 has a first inside diameter and in the second
configuration the inner tubular member 1010 has a second inside
diameter that is less than the first inside diameter.
[0092] In the illustrated embodiment, the inner tubular member 1010
is formed of a first material that has a first hardness and the
compressible member 818 is formed of a second material that has a
second hardness that is greater than the first hardness. For
example, the first material can have a first durometer hardness
that is less than the durometer hardness of the second material.
The inclusion of an inner tubular member having a hardness that is
less than the hardness of the compressible member is considered
advantageous at least because it provides a mechanism for reducing
any damage to a medical device that is disposed through a rotatable
control handle that includes compressible member 818.
[0093] While the inner tubular member 1010 has been illustrated as
being partially disposed within compressible member 818, as being
formed of a first material that is different than the second
material forming the compressible member 818, as having a
particular structural arrangement, and as being attached to the
compressible member using an adhesive, an inner tubular member
included in a compressible member can be formed of any suitable
material, have any suitable structural arrangement, and be attached
to a compressible member using any suitable technique or method of
attachment. Selection of a suitable material to form an inner
tubular member, a structural arrangement for an inner member, and a
technique or method of attachment between an inner tubular member
and a compressible member can be based on various considerations,
including the materials forming a compressible member of which the
inner tubular member is a component. Examples of materials
considered suitable to form an inner tubular member include
biocompatible materials, materials that can be made biocompatible,
metals such as stainless steel, titanium, brass, nickel-titanium
alloys (e.g., Nitinol), polymers, Pebax, nylon, polyethylene,
polyurethane, silicone, combinations of the materials described
herein, and any other material considered suitable for a particular
application. Examples of suitable lengths of an inner tubular
member to position within a passageway defined by a compressible
member include partial lengths, entire lengths, and any other
length considered suitable for a particular embodiment. Examples of
structural arrangements considered suitable for an inner tubular
member include arrangements that omit the inclusion of a notch,
that include more than two notches, that include one or more
notches that extends along a portion of the length of the tubular
member, and any other structural arrangement considered suitable
for a particular embodiment. Examples of techniques and methods of
attachment considered suitable between an inner tubular member and
a compressible member include using an adhesive, welding, fusing,
and any other technique or method considered suitable for a
particular embodiment.
[0094] FIGS. 16, 17A, and 17B illustrate an alternative
compressible member 1118 suitable for use in a rotatable control
handle according to an embodiment. The compressible member 1118 is
similar to the compressible member 1018 illustrated in FIGS. 14 and
15, and described above, except as detailed below. The compressible
member 1118 has a lengthwise axis 1163, a first end 1164, a second
end 1166, a length 1167, and a body 1168 that defines a base 1170,
a passageway 1172, a first arm 1174, a second arm 1176, a third arm
1178, and a fourth arm 1180.
[0095] In the illustrated embodiment, the body 1168 of the
compressible member 1118 defines a continuous surface 1194 on the
head 1192 of each of the arms 1174, 1176, 1178, 1180 (e.g., each
arm omits a recess and projection), a first conical recess 1196,
and a second conical recess 1197 when the compressible member 1118
is in the first configuration. The first conical recess 1196
extends from the first end 1164 toward the second end 1166 and
provides a mechanism for directing any medical device passed
through the compressible member 1118 into the passageway 1172. The
second conical recess 1197 extends from the second end 1166 toward
the first end 1164 and provides a mechanism for increasing the
surface area that contacts a medical device passed through the
compressible member 1118 during use and when the compressible
member 1118 is in the second configuration, as shown in FIG. 17B.
The inclusion of a second conical recess 1197 is considered
advantageous at least because it increases the fixation between the
compressible member 1118 and any medical device disposed through
the compressible member 1118, which provides an increase in the
amount of torque that can be applied on the medical device during
use.
[0096] While the compressible member 1118 has been illustrates as
having two conical recesses 1196, 1197, a compressible member can
include any suitable number of recesses, having any suitable
structural arrangement, and formed using any suitable technique.
Selection of a suitable number of recesses to include on a
compressible member, suitable structural arrangement for a recess,
and technique to form a recess can be based on various
considerations, including the material that forms the compressible
member. Examples of numbers of recess to include on a compressible
member include zero, one, at least one, two, a plurality, and any
other number of recesses considered suitable for a particular
embodiment. Examples of structural arrangements for a recess
included on a compressible member include conical, frustoconical,
cylindrical, and any other structural arrangement considered
suitable for a particular embodiment. An example technique
considered suitable to form a recess includes moving a compressible
member to the second configuration forming the structure of the
recess (e.g., using a drill or other tool) and then allowing the
compressible member to return to the first configuration.
[0097] Those with ordinary skill in the art will appreciate that
various modifications and alternatives for the described and
illustrated embodiments can be developed in light of the overall
teachings of the disclosure. Accordingly, the particular
arrangements disclosed are intended to be illustrative only and not
limiting as to the scope of the invention, which is to be given the
full breadth of the appended claims and any and all equivalents
thereof.
* * * * *